STEADY-STATE PHARMACOKINETICS OF A MULTIPARTICULATE MATRIX SUSTAINED-RELEASE THEOPHYLLINE PREPARATION

Authors
Citation
Kk. Peh et Kh. Yuen, STEADY-STATE PHARMACOKINETICS OF A MULTIPARTICULATE MATRIX SUSTAINED-RELEASE THEOPHYLLINE PREPARATION, Drug development and industrial pharmacy, 22(11), 1996, pp. 1133-1138
Citations number
17
Categorie Soggetti
Pharmacology & Pharmacy
ISSN journal
03639045
Volume
22
Issue
11
Year of publication
1996
Pages
1133 - 1138
Database
ISI
SICI code
0363-9045(1996)22:11<1133:SPOAMM>2.0.ZU;2-0
Abstract
A novel multiparticulate matrix sustained-release theophylline prepara tion was evaluated in comparison with a reference product, Neulin-SR(R ), in a multiple-dose administration study, conducted according to a r andomized, two-way crossover design involving 12 healthy volunteers. C omparison was made using the parameters, area under the serum concentr ation-time curve from time 0 to 12 hr (AUC(0-12)), time to reach peak serum concentration (T-max), peak serum concentration (C-max), trough serum concentration (C-min), average drug concentration (C-av), degree of fluctuation (DF), percentage of time serum drug concentrations lie within the therapeutic range (occupancy time) and time for 50% of dos e absorbed (T-50%). The parameters, C-max, C-min, AUC(0-12), C-av, and DF were logarithmic transformed prior to statistical analysis. A stat istically significant difference was obtained between the values of th e two preparations in the T-max, C-min, DF, and T-50%; but not in the C-max, AUC(0-12), C-av, and occupancy time. These findings suggest tha t the novel preparation has a more sustained rate but equivalent exten t of absorption compared to Neulin-SR, leading to a more uniform stead y-state serum profile.